FDA.reportPublic FDA data

Reef Babies SPF 50 Oxybenzone Free

Product NDC
52854-515
11-digit product format
528540515
Labeler code
52854
Product ID
52854-515_42c9f018-98d9-575f-e063-6394a90a2566
Type
HUMAN OTC DRUG
Nonproprietary name
octocrylene, octisalate, and avobenzone
Dosage form
LOTION
Route
TOPICAL
Labeler
Tropical Seas, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-05-01
Substance
OCTOCRYLENE; OCTISALATE; AVOBENZONE
Active strength
10; 5; 3 g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Reef Babies SPF 50 Oxybenzone Free
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTOCRYLENE10 g/100mL
OCTISALATE5 g/100mL
AVOBENZONE3 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5A68WGF6WMInternal UNII lookup
4X49Y0596WInternal UNII lookup
G63QQF2NOXInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8cd68b09-2578-4519-b00e-e83e0e440815Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52854-515-01Reef Babies SPF 50 Oxybenzone Free120 mL in 1 BOTTLE, PLASTICLOTION1208
52854-515-02Reef Babies SPF 50 Oxybenzone Free192 mL in 1 BOTTLE, PLASTICLOTION1928

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52854-515REEF BABIES SPF 50 OXYBENZONE FREE (OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.]7Current NDC, Legacy NDC, 2 package rows20241103_8cd68b09-2578-4519-b00e-e83e0e440815.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 161 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Soft Bisque Perfecting Makeup SPF 25 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Ince8b11940-6ac4-4c80-a732-2f86f2b7ebfe2025-11-19WarningsExact identifier
application number: M020
Timeless Illuminating Makeup SPF 30 Alabaster Merle NormanOCTINOXATE, OXYBENZONEMerle Norman Cosmetics, Incd54a35a2-4f5d-4aec-8be4-1d8e00d4618f2025-11-19WarningsExact identifier
application number: M020
Timeless Illuminating Makeup SPF 30 Alabaster Beige Merle NormanOCTINOXATE, OXYBENZONEMerle Norman Cosmetics, Incd6be5b8e-0094-40de-91a6-bc52b3f8a9872025-11-19WarningsExact identifier
application number: M020
Timeless Illuminating Makeup SPF 30 Creamy Beige Merle NormanOCTINOXATE, OXYBENZONEMerle Norman Cosmetics, Incda149594-8a75-4b8d-9b6a-068231ce153b2025-11-19WarningsExact identifier
application number: M020
Timeless Illuminating Makeup SPF 30 Pure Beige Merle NormanOCTINOXATE, OXYBENZONEMerle Norman Cosmetics, Inc95821b1c-c894-4b3f-94c2-0083497302032025-11-19WarningsExact identifier
application number: M020
Timeless Illuminating Makeup SPF 30 Porcelain Merle NormanOCTINOXATE, OXYBENZONEMerle Norman Cosmetics, Inccce60274-ef8a-4638-a2c8-e869fc9e2a7c2025-11-19WarningsExact identifier
application number: M020
Timeless Illuminating Makeup SPF 30 Quiet Rose Merle NormanOCTINOXATE, OXYBENZONEMerle Norman Cosmetics, Inc776f5cb5-9d0e-4057-9600-e18b2b8a249a2025-11-19WarningsExact identifier
application number: M020
Timeless Illuminating Makeup SPF 30 Sandy Beige Merle NormanOCTINOXATE, OXYBENZONEMerle Norman Cosmetics, Inc2406806e-f5ff-4c54-bf33-a96afaea1ccc2025-11-19WarningsExact identifier
application number: M020
Timeless Illuminating Makeup SPF 30 Sesame Merle NormanOCTINOXATE, OXYBENZONEMerle Norman Cosmetics, Inc70b94df9-2160-450c-a722-cb842f58c3192025-11-19WarningsExact identifier
application number: M020
Timeless Illuminating Makeup SPF 30 Simply Beige Merle NormanOCTINOXATE, OXYBENZONEMerle Norman Cosmetics, Inc7797fcb4-2080-415a-9b4b-5410518380932025-11-19WarningsExact identifier
application number: M020
Timeless Illuminating Makeup SPF 30 Soft Bisque Merle NormanOCTINOXATE, OXYBENZONEMerle Norman Cosmetics, Ince5a63ffc-32e6-4bb1-907a-8697791f57bf2025-11-19WarningsExact identifier
application number: M020
Vanilla Perfecting Makeup Broad Spectrum SPF 25 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc98ebaa5c-ba28-4e70-a45c-6545eb756d8f2025-11-19WarningsExact identifier
application number: M020
Softlips VanillaDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company8dff782f-7201-4ad9-94d2-672058f817b82025-11-19WarningsExact identifier
application number: M020
Lanolips Sun Balm Tropical Untinted Lip Balm Broad Spectrum SPF30AVOBENZONE, OXTINOXATE, OCTOCRYLENE, OXYBENZONEBaxter Laboratories Pty. Ltd.43923c68-87ad-1ab7-e063-6394a90adf7a2025-11-18WarningsExact identifier
application number: M020
Illuminizing Blendrops Broad Spectrum SPF 46HOMOSALATE, OCTISALATE, ZINC OXIDEWasatch Product Development, LLC43e36351-4caf-3393-e063-6394a90a00b12025-11-18WarningsExact identifier
application number: M020
Perfecting Blendrops Broad Spectrum SPF 46HOMOSALATE, OCTISALATE, ZINC OXIDEWasatch Product Development, LLC43e454cf-dac8-4c2f-e063-6394a90a70972025-11-18WarningsExact identifier
application number: M020
Hill Country Fare Morning Facial Moisturizing with Broad Spectrum SPF 30 SunscreenHOMOSALATE, OCTOCRYLENE, ZINC OXIDEH.E.B.43e55eb7-6572-bd88-e063-6294a90aa7ee2025-11-18WarningsExact identifier
application number: M020
Bare Expert Finish Makeup Broad Spectrum SPF 25 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Incff396aca-cf64-45f8-ba2e-c4fc55d6484b2025-11-18WarningsExact identifier
application number: M020
ANTI-AGING COMPLEX BROAD SPECTRUM SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEMerle Norman Cosmetics, Inc.d10272ea-aedd-5759-e053-2a95a90a3ab32025-11-18WarningsExact identifier
application number: M020
DAYDREAM Broad Spectrum Sunscreen SPF 40ZINC OXIDEDrmtlgy, LLCbd0981cb-49ce-4eaf-bd9e-db48f56b73142025-11-18WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52854-515-0152854051501120 mL in 1 BOTTLE, PLASTIC (52854-515-01) 120 ml2017-05-010000-00-00NoNoCurrent
52854-515-0252854051502192 mL in 1 BOTTLE, PLASTIC (52854-515-02) 192 ml2022-11-140000-00-00NoNoCurrent